By Andrew E. Sama, MD, FACEP
With nearly two-thirds of all admitted septic patients presenting to the ED, and with the clear time sensitivity that exists between recognition, treatment, and outcomes, our members are on the front lines to save lives from this frequently fatal disease. In the CY 2015 IPPS rule, in which CMS cited the fact that “that patients admitted through the ED had a 17% lower likelihood of dying from sepsis than when directly admitted,” CMS finalized NQF #0500: Early Management Bundle for Severe Sepsis and Septic Shock, which mandated the invasive monitoring of CVP and ScVO2 via the placement of a central line in the ED. However, late on Friday, CMS notified hospitals, that it will suspend data collection for the Severe Sepsis and Septic Shock: Management Bundle measure (NQF #0500) until further notice.
Emanuel Rivers, MD, MPH, and his team improved mortality and raised the awareness of the EM community about sepsis through their Early Gold Directed Therapy (EGDT) study in the early 2000s. A few years later, the measure was initially endorsed by the NQF in 2008 without the requirement for a central line for the emergency department. While it is certain that early intervention does reduce mortality, not all elements of the sepsis composite bundle were equally evidence-based. Many studies over the years have demonstrated dramatic improvements in sepsis-related mortality after the implementation of early interventions for septic patients, which included early antibiotic administration, source control, and aggressive fluid resuscitation without invasive monitoring of CVP and ScVO2. One study addressing this, authored by Dr. Alan Jones and colleagues, was conducted at three EDs in the US, and compared two protocols that both included central venous pressure measurement; however, one used lactate clearance and the other used central venous oxygenation monitoring as a way to guide resuscitation. Dr. Jones’ 2010 study found no differences in mortality, suggesting that using central venous oxygenation to guide resuscitation may not be necessary.
In 2012 the measure underwent routine NQF maintenance review for re-endorsement in 2012-2013. During those proceedings, under the leadership of David Seaberg, MD, FACEP and myself ACEP commented that central venous pressure (CVP) was not the only reliable measure of intravascular volume. Several members of ACEP’s Quality and Performance Committee (QPC) including chair Jeremiah D. Schuur, MD, MHS, FACEP, Michael Phelan, MD, RDMS, FACEP, Todd Slessinger, MD, FACEP, FCCM, FCCP, Christopher Fee, MD, FACEP, and others testified on conference calls and at in-person meetings, that there were equally effective and less invasive methods for monitoring septic patients. Nonetheless, the NQF endorsed the requirement for the central line, noting that they would re-consider if additional evidence warranted it.
Within a few months the Protocolized Care for Early Septic Shock (ProCESS) trial was published on March 18, 2014 and under Dr. Alexander Rosenau’s leadership ACEP immediately requested that NQF #0500 undergo an ad hoc review given the impact that this new data would have on this quality measure. After reviewing the data from the ProCESS trial, NQF questioned whether NQF #0500’s item ‘F’, which measures central venous pressure and central venous oxygen saturation, should be retained or removed from the measure. During the review, one of the PIs, Donald Yealy, MD, FACEP engaged in a scientific debate noting that the ProCESS trial enrolled 1,341 patients, with a power to detect a 6-7 percent absolute difference, yet demonstrated no difference in mortality 60-day mortality 90-day mortality, one year mortality, or the need for organ support. The ProCESS also noted no benefit in any outcome when using CVC- guided care and the simpler approaches that stressed early and ongoing care produced the same good outcomes.
CMS, NQF, and others are now also convinced that honing the sepsis bundle is a move forward for our septic patients, with or without invasive monitoring depending on the progression of their disease, their unique circumstances, and the resources available at the ED where they are being treated. As it is ACEP’s mission, we will continue to advocate on behalf of our patients presenting with a diagnosis of sepsis to ensure that they receive the highest quality of emergency care. We look forward to continuing to work with the measure developer to ensure that all septic patients receive the timely, effective care they need, and to continue to save lives from this deadly disease.
Dr. Sama is ACEP’s Immediate Past President and Chair of the Board of Directors
In a recent newsletter, the American Hospital Association informed its members of a change by CMS as it relates to data collection for severe sepsis and sepsis shock. Below is the CMS announcement.
The Centers for Medicare & Medicaid Services (CMS) is notifying hospitals participating in the Hospital Inpatient Quality Reporting (IQR) Program that it will suspend data collection for the Severe Sepsis and Septic Shock: Management Bundle measure (NQF #0500) until further notice. This measure was adopted for the FY 2017 payment determination in the CY 2015 IPPS final rule.
CMS continues to believe that this is an important area for measurement given mortality rates that range from 16-49% and that sepsis is one of the top 10 most common principle causes for hospitalizations. Further, through surveillance of early effective treatment of severe sepsis or septic shock, hospitals will not only know where in the sequence of steps to treat severe sepsis and septic shock patients, but also begin to decrease mortality related to sepsis and the costs associated with inefficient care of severe sepsis and septic shock patients. With this measure CMS will gauge if care of severe sepsis and septic shock patients is improving.
This measure was initially endorsed by the NQF in 2008 for the hospital/acute care facility setting and underwent routine NQF maintenance review for re-endorsement in 2013. During the 2013 NQF endorsement proceedings it was noted that should new data be published related to the measure, that the measure would undergo an ad hoc review. With publication of the Protocolized Care for Early Septic Shock (ProCESS) trial in early 2014, NQF #0500 underwent an ad hoc review to discern if the new data would impact the measure as currently designed. After reviewing the data from the ProCESS trial, NQF questioned whether NQF #0500’s item ‘F’, which measures central venous pressure and central venous oxygen saturation, should be retained or removed from the measure. During the review two other trials were identified that might also impact NQF #0500, those trials are the Australian Resuscitation in Sepsis Evaluation Randomized Controlled Trial (ARISE) and The Protocolised Management in Sepsis Trial (ProMISe). After much discussion of the results of the ProCESS trial, the potential impact the ARISE and ProMISe trials may have on the measure, and the recommendations to remove item ‘F’ from the measure, NQF recommended that measure stewards collaborate with other stakeholders to reach a compromise on NQF #0500’s item F. NQF recommended that measure developers collaborate with other stakeholders to reach a compromise on this specific element of NQF #0500 measure.
Given forthcoming research and NQF’s recommendations, with potential changes to the measure, CMS will delay data collection for the measure until further notice. The duration of this suspension pending further information from the measure developer has not yet been determined. This delay does not affect the data collection period for any other Hospital IQR Program measures.
By Dennis Beck, MD, FACEP
ACEP is working with a leading registry vendor who currently provides PQRS registry reporting for more than 40 medical societies. The penalty for failure to satisfy the 2014 PQRS requirements equals up to 4% of Medicare payments, approximately $2,500 per provider.
As a member benefit, ACEP is providing ACEP, EMRA & SEMPA members with $100 off the $299 per provider fee. We have negotiated a deeper discount of 10% off ($179) for groups of 10 or more and 15% ($169) for groups of 20 or more. For more information on reporting requirement, go to www.acep.org/qualityregistry. And be sure to return on Sept. 1 to take advantage of this member benefit.
In 2014 a group of 10 or more eligible professionals may avoid the 2% PQRS penalty as well as the 2% VBM penalty (both applied to 2016 payments) if at least 50% or more of the individual eligible professionals in the group satisfy PQRS reporting requirements in 2014. Even just one Medicare Fee-For-Service claim for the calendar year qualifies a provider (physician or midlevel) as an eligible professional in a group for purposes of the “50% threshold.” However, please note that those eligible professionals in the group, who do not submit PQRS measures, will still be subject to the PQRS payment adjustment of 2%. To avoid the VBM penalty, at least 50% of individual EPs in a group must meet the minimum PQRS reporting requirements (for more information on these requirements visit www.acep.org/quality. So the choice of whether to report as individuals or to report as a group is a decision that is up to your group.
If your group decides to participate in the 2014 PQRS group practice reporting option (GPRO), the group is required to register through the Physician Value-Physician Quality Reporting System (PV-PQRS) Registration System by September 30, 2014. This registration process can take up to two weeks, so start now! Groups will need an Individuals Authorized Access to the CMS Computer Services (IACS) account to access the PV-PQRS Registration System. Registration lets CMS know which groups want to be analyzed at the group level (or TIN-level analysis).
Complete information about IACS and 2014 PQRS GPRO registration is available on the CMS website. Click here for that information.
During registration, the group practice will need to indicate the size of their group at the time they register. For GPRO Group size is based on the number of eligible professionals including PAs and NPs billing under the TIN. Be sure that your group’s Medicare Provider Enrollment, Chain, and Ownership System (PECOS) information is updated for before you begin registration.
Whatever your decision, to report as a group via GPRO registry or to report as individuals, the ACEP PQRS Wizard registry option will be available for you. Although you can upload quality data codes from your practice management, coding, or billing software to the portal through February of 2014, if you want to participate via GPRO your group must complete the PV-PQRS registration process by September 30, 2014. If you plan to report as individuals you can sign up through Dec. 31, 2014.
Dr. Beck is President and CEO of Beacon Medical Services in Aurora, Colorado. He is past chair and current member of the ACEP Reimbursement, Quality and Performance Committees. Dr. Beck is also a member of the ACEP Coding and Nomenclature Committee and chair of the Colorado ACEP Finance Network.
Check out the August audio here. New format! More clinician-focused than ever. Highlights include:
-ED visits and healthcare reform in Massachusetts: what happens when more people become insured?
-Chest pain risk tolerance: does anyone know what they’re talking about?
-Pediatric minor head injury: we found the rule you should be using….
-MOLST/POLST: get to know it — this changes everything.
Pleeeease give us your feedback, at email@example.com
July’s audio/podcast for Annals of EM is now posted here. Highlights:
-Early vs late rhythm analysis in OOHCA
-Ground based EMS transports and complications
-When do sepsis patients become septic? Usually NOT on arrival. Time to change the metric?
-Diethylene glycol outbreak
-Much, much more!
The ACEP Board Directors accepted a recommendation last week from its Clinical Policies Committee to begin working on a tPA policy exclusive to ACEP instead of a joint project with the American Academy of Neurology.
The 2013 Council had asked that ACEP reconsider its current “Clinical Policy: Use of Intravenous tPA for the Management of Acute Ischemic Stroke in the Emergency Department,” which had been developed with the AAN and published in February 2013.
After an open 60-day comment period in early 2014 and a subcommittee review of the comments and literature findings, the Clinical Policies Committee recommended to pursue an independent policy, which will include updated evidence and grading criteria. The Board unanimously approved this recommendation.
Once the draft is developed, it will be available for members to review and comment for 60 days prior to the Committee’s presentation to the Board. An estimated timeline was not available.
Additionally, the Board confirmed its commitment to the clinical policy development process and agreed to add three methodologists to the committee, additional meetings, and another staff person to ensure a robust review process.
By James M. Cusick, MD, FACEP
Chair, Candidate Forum Subcommittee of the ACEP Council
ACEP is a member-driven organization with a representative body of our peers – the ACEP Council – chosen through component bodies, including our chapters (1 representative per 100 members), our Sections of Membership, and other aligned organizations.
Each year, this body democratically votes to establish ACEP policy and elect leadership positions. Candidates present themselves to the Council through written statements, scheduled speeches, and unrehearsed Question and Answer sessions during the Candidate Forum, which is open to all members. Elections must be fair, follow guidelines applicable to all, and be free of undue influence or pressure on candidates.
The ACEP Council’s Candidate Forum Subcommittee recently performed its annual review of the campaign rules to ensure a fair campaign and elections process for all Board of Directors and President-elect candidates. The changes were approved by the Council Steering Committee.
This year, restrictions on the use of social media were substantially relaxed to allow forms of communication most of us use on a daily basis.
In addition, protections were incorporated into the rules to keep candidate interviews in ACEP publications. Our goal is to avoid candidates being put in the position of commenting on College policy without adequate preparation and to ensure that the campaign process is fair and equal for all candidates.
Certain candidates may unfairly benefit from coverage in non-ACEP publications, while some may be disadvantaged. In order to ensure a fair election, campaign questions and the vetting of candidates is the responsibility of ACEP, its Council and its Council Committees.
If there are specific questions you would like asked of the candidates prior to the election, please send them to firstname.lastname@example.org. The Candidate Forum Subcommittee will consider them, the selected questions will be posed to candidates and their responses will be made public.
Elections will occur during the Council meeting on Oct. 26 in Chicago. The Nominating Committee has selected the final slate of candidates for 2014:
Jay Kaplan, MD, FACEP
Robert O’Connor, MD, FACEP
Rebecca Parker, MD, FACEP
Board of Directors Candidates (4 positions to be filled)
Stephen Anderson, MD, FACEP (WA)
Jon Mark Hirshon, MD, FACEP (MD)
Hans House, MD, FACEP (incumbent – IA)
Mark Mackey, MD, FACEP (incumbent – IL)
John Rogers, MD, FACEP (incumbent – GA)
Mark Rosenberg, DO, FACEP (NJ)
The Annals of EM June audio is posted and available. Highlights:
-How important is isolated vomiting in children as a predictor of TBI?
-The yield of ‘clearance’ laboratory testing for pediatric psych patients
-Confirming femoral lines with a saline flush—it works
-Should hydromorphone dosing be weight-based?
-Intranasal fentanyl for EMS
-Transgender populations in the ED: the experience
-Incidence of delayed anaphylaxis in the ED
And much much more…
Email any time at email@example.com.
By Justin McNamee, DO; Nilesh Patel, DO; and Joseph Affortunato, DO
Department of Emergency Medicine
St. Joseph’s Regional Medical Center, Paterson, New Jersey
A 26-year-old woman presented to the emergency department, complaining of a 3-day history of lower abdominal pain and vaginal bleeding. She reported positive home pregnancy test results and that her last menstrual period was 17 weeks ago. On examination, the patient appeared comfortable and was afebrile, with a blood pressure of 131/67 mm Hg, pulse rate of 100 beats/min, and respiratory rate of 16 breaths/min.
Clinical Policy: Critical Issues in the Evaluation and Management
of Adult Patients Presenting to the Emergency Department With Seizures
By J. Stephen Huff, MD, FACEP
In the April 2014 issue of the Annals of Emergency Medicine, the American College of Emergency Physicians (ACEP) published a clinical policy focusing on seizures. This is a revision of a 2004 clinical policy with the same name.
This clinical policy can also be found on ACEP’s website www.acep.
This clinical policy takes an evidence-based approach to answering four frequently encountered questions with regards to decision making associated with seizures in the emergency department. Recommendations (Level A, B, or C) for patient management are provided based on the strength of evidence using the Clinical Policies Committee’s well-established methodology:
Level A recommendations represent patient management principles that reflect a high degree of clinical certainty; Level B recommendations represent patient management principles that reflect moderate clinical certainty; Level C recommendations represent other patient management strategies based on Class III studies, or in the absence of any adequate published literature, based on consensus of the members of the Clinical Policies Committee.
During development, this clinical policy was reviewed and expert review comments were received from emergency physicians, neurologists, and individual members of the American Epilepsy Society, the American Academy of Neurology, the Epilepsy Foundation of America, the National Association of Epilepsy Centers, and ACEP’s Quality and Performance Committee. The draft was also open to further comments through various ACEP communication pieces. All responses were used to further refine and enhance this policy; however, their responses did not imply endorsement of this clinical policy.
This revision of the clinical policy on critical issues in the evaluation and management of adult patients with seizures in the emergency department focused on selected critical questions. Key to this policy revision was employing updated nomenclature for classification of seizures. Seizures can be thought of as provoked or unprovoked. Provoked seizures are secondary to electrolyte disturbances, toxins, infections, central nervous system mass lesions, withdrawal syndromes, or other etiologies. These provoked seizures, also known as acute symptomatic seizures, by definition occur at the time of or within seven days of acute neurologic, systemic, metabolic, or toxic processes. Unprovoked seizures occur in the absence of acute precipitating factors. Seizures from such processes as stroke, brain injury, and other CNS insults that occurred more than seven days in the past are also classified as unprovoked seizures. Epilepsy is defined by recurrent unprovoked seizures.
The question of initiating treatment with antiepileptic drugs for the adult patient presenting to the ED following a first generalized seizure who has returned to baseline clinical status was one critical question. The short-term recurrence risk of this group of patients is unknown but thought to be low. After literature review and grading the evidence, level C recommendations were developed for subgroups of patients. Appropriate clinical assessment by emergency physicians of patients is important since presumptive assignment of the seizure as provoked or unprovoked drives the treatment recommendation. However, it is unclear if seizures can be precisely identified as provoked or unprovoked using information available during an emergency department evaluation. Additionally, patient safety should remain a paramount concern for the practicing physician. Though the evidence supports discharging an adult patient who has returned to baseline status following a first unprovoked seizure, supporting articles assumed a safe support system for the discharged patient. Consideration of social issues or other factors may prompt consideration for admission.
Another critical question addressed treatment of ED patients with generalized convulsive status epilepticus who continue to have seizures despite receiving optimal dosing of a benzodiazepine. There are remarkably few randomized prospective studies on this problem and none that consider the causes of status epilepticus. Large prospective studies are in the planning stages. Until these studies are completed, recommendations for specific drugs must reflect current lower levels of evidence. Many different medications are recommended and no medication or class of medications is clearly superior.
Designation of a seizure as provoked or unprovoked at some level is arbitrary and may change with the clinical course or as additional studies are performed. Emergency physicians play a critical role in determining whether a seizure is provoked or unprovoked. If there is an underlying medical condition, identification and treatment of that process is the primary consideration. It is hoped that future studies will focus on seizure recurrence of patients presenting to the ED with seizures, and study outcomes over days or another time frame relevant to emergency medicine.
Critical Questions and Recommendations
Question 1: In patients with a first generalized convulsive seizure who have returned to their baseline clinical status, should antiepileptic therapy be initiated in the ED to prevent additional seizures?
Level C recommendations.
(1) Emergency physicians need not initiate antiepileptic medication* in the ED for patients who have had a first provoked seizure. Precipitating medical conditions should be identified and treated.
(2) Emergency physicians need not initiate antiepileptic medication* in the ED for patients who have had a first unprovoked seizure without evidence of brain disease or injury.
(3) Emergency physicians may initiate antiepileptic medication* in the ED, or defer in coordination with other providers, for patients who experienced a first unprovoked seizure with a remote history of brain disease or injury.
* Antiepileptic medication in this document refers to medications prescribed for seizure prevention.
Question 2: In patients with a first unprovoked seizure who have returned to their baseline clinical status in the ED, should the patient be admitted to the hospital to prevent adverse events
Level C recommendations. Emergency physicians need not admit patients with a first unprovoked seizure who have returned to their clinical baseline in the ED.
Question 3: In patients with a known seizure disorder in which resuming their antiepileptic medication in the ED is deemed appropriate, does the route of administration impact recurrence of seizures?
Level C recommendations. When resuming antiepileptic medication in the ED is deemed appropriate, the emergency physician may administer IV or oral medication at their discretion.
Question 4: In ED patients with generalized convulsive status epilepticus who continue to have seizures despite receiving optimal dosing of a benzodiazepine, which agent or agents should be administered next to terminate seizures?
Level A recommendations. Emergency physicians should administer an additional antiepileptic medication in ED patients with refractory status epilepticus who have failed treatment with benzodiazepines.
Level B recommendations. Emergency physicians may administer intravenous phenytoin, fosphenytoin, or valproate in ED patients with refractory status epilepticus who have failed treatment with benzodiazepines.
Level C recommendations. Emergency physicians may administer intravenous levetiracetam, propofol, or barbiturates in ED patients with refractory status epilepticus who have failed treatment with benzodiazepines.
Dr. Huff is Professor of Emergency Medicine and Neurology, University of Virginia, Charlottesville, Virginia